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병원 진단검사의학부의 공간구조와 설비기준에 대한 조사 - 미국, 영국, 독일을 중심으로

A Study on the Space Organization and Facility Equipment of Medical Laboratory - focusing on the USA, UK and Germany -


Purpose: As medicare services have gotten spreaded, clinical laboratory has been dominant position. So, it has been acted for quality control and clinical pathology accreditation. But there has been quite deficient information to evaluate working space and technical standards of medical laboratory for accreditation. This study goals to figure out accreditation standard and design guideline for clinical laboratory, and to give safe and efficient design information. Methods: This study has been searched by literature for accreditation standards and design guidelines of clinical pathology in USA, UK, and Germany. Results: Three countries have accredited based on working lab space, staff space, storage space, patient space and health and safety equipment. Design guidelines of three countries commonly have focused on worktable layout, worktable distance and module, and specific laboratory biosafety level. And USA guidelines stress on the architectural design such as design process and passage distance for escape, UK stress on the efficiency as functional work flow and construction cost, lastly Germany design guidelines stress on the operator's safety distance and workstation. Three countries have not only accreditation standards but also design guidelines for more specific quality management, separating from accrediting institute. Implications: In korea, it has been needed to make clinical laboratory design guideline for the safe and efficient environment and reliable and competitive medical service.

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참고문헌 (13)

  1. Clinical and Laboratory Standards Institute, QMS04-A2 Laboratory Design;Approved Guideline-2nd Edition, 
  2. Clinical Pathology Accreditation(UK) Ltd, Standards for the Medical Laboratory, Nov 2010 
  3. Daniel M. Baer, Redesigning the lab for today's workflow, Medical Laboratory Observer, Oct 1989 
  4. Darlene Berger, A brief history of medical diagnosis and the birth of the clinical laboratory, Part1,2,3, www.mlo-online.com 
  5. Deutsche Gesetzliche Unfallversicherung e.V., BGI/GUV-I 8681-1: Neu-und Umbauplanung im Krankenhaus unter Gesichtspunken des Arbeitsschutzes, Berlin, Sep 2011 
  6. DIN EN ISO 15189:2014 for Medical Laboratories 
  7. Karen K. Mortland, Laboratory Design for Today's Tchnologies, Mes TechNet Presentation, May 1997 
  8. Laboratory Medicine Foundation, Working Lab General Checklist, 2014 
  9. NHS Estates, HBN 15 Facilities for pathology services, April 2005 
  10. Quality Assurance, The Korean Society of Pathologists/The Korean Society of Cytopathology, G-2015 Red Book-General Checklist 
  11. Wee-Gyo Lee, A study on standardization of clinical laboratories for prevention and control of chronic diseases, Centers for Disease Control & Prevention, 2011 
  12. www.ukas.com/services/CPA/Clinical_Pathology_Accreditation_CPA 
  13. Young-Joo Cha, etc, Quality Assurance for Laboratory Medicine, National Health Insurance Service, 2007 

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